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SURGIMEDIA: Utilization of Multimedia for Enhanced Surgical Consent

NCT07494994 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-08-26

No results posted yet for this study

Summary

Informed consent is an ethical and legal component of the pre-procedural process. Informed consent involves the explanation of procedural steps and discussion regarding the risks, benefits, and alternatives of the proposed procedure. The current informed consent process lacks standardization, and patient experience can vary widely depending on the provider obtaining consent. This pilot study aims to ensure high quality informed consent for patients undergoing a complex oncologic operation known as a pancreaticoduodenectomy (Whipple operation), through the creation of an educational video as a method of obtaining informed consent. This study will explore whether the application of an educational video as part of the informed consent process increases patient understanding, comfort, and overall satisfaction throughout the Whipple operative course. The primary objective of this study is to determine whether implementation of a multimedia video as an enhancement to surgical informed consent improves patient satisfaction, promotes understanding, and informs operative expectations. The desired outcome is to standardize the informed consent process to eliminate variability in the quality of the consent process and to mitigate the impact of healthcare barriers such as health literacy and language proficiency in the informed consent process.

Conditions

  • Pancreas Cancer

Interventions

BEHAVIORAL

Standard Informed Consent

Participants receive the institution's standard verbal informed consent discussion delivered by a qualified provider, covering the Whipple operation, expected outcomes, risks, benefits, and alternatives. The provider answers follow-up questions.

BEHAVIORAL

Multimedia Video - Based Informed Consent

Participants view a narrated, animated video explaining the Whipple procedure; benefits, alternatives, and potential perioperative and postoperative complications; and resources for recovery. Afterward, a provider answers questions.

Sponsors & Collaborators

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Jen J Yeh, MD · UNC Lineberger Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2030-01-31
Completion
2030-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07494994 on ClinicalTrials.gov